Bromazepam use while Breastfeeding

Summary of Use during Lactation

Bromazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration but is available in other countries. The death of a newborn infant breastfed by a mother who was apparently using bromazepam has been reported. If a mother of an older infant requires bromazepam, it is not a reason to discontinue breastfeeding; however, an alternate drug is preferred, especially while nursing a newborn, preterm or sick infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A 4-week-old infant with a 5-day history of near-miss sudden infant death syndrome was brought to the emergency room with asystole and unresponsive pupils. Despite resuscitation, the infant died. The infant’s serum contained a plasma concentration of 0.38 mcg/mL of “diazepam equivalents” and the infant’s urine was positive for bromazepam. The mother appeared to have been taking sedatives over the last few days, while partially breastfeeding, because of nervousness and sleeplessness.[1] Bromazepam probably contributed to the infant’s death.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Anxiety) Lorazepam, Oxazepam, Temazepam

References

1.

Martens PR. A sudden infant death like syndrome possibly induced by a benzodiazepine in breast-feeding. Eur J Emerg Med 1994;1:86–7. [PubMed: 9422145]

2.

Anderson PO, Pochop SL, Manoguerra AS. Adverse drug reactions in breastfed infants: Less than imagined. Clin Pediatr (Phila) 2003;42:325–40. [PubMed: 12800727]

Substance Name

Bromazepam

CAS Registry Number

1812-30-2

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Anxiety Agents

Benzodiazepines

GABA Modulators

Hypnotics and Sedatives